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WO2013008176A1 - Rétracteur - Google Patents

Rétracteur Download PDF

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Publication number
WO2013008176A1
WO2013008176A1 PCT/IB2012/053516 IB2012053516W WO2013008176A1 WO 2013008176 A1 WO2013008176 A1 WO 2013008176A1 IB 2012053516 W IB2012053516 W IB 2012053516W WO 2013008176 A1 WO2013008176 A1 WO 2013008176A1
Authority
WO
WIPO (PCT)
Prior art keywords
retractor
dilator
guide surface
surface portions
lower guide
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2012/053516
Other languages
English (en)
Inventor
Oded Loebl
Avi SHTERLING
Tzony Siegal
Didier Toubia
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
NLT Spine Ltd
Original Assignee
NLT Spine Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by NLT Spine Ltd filed Critical NLT Spine Ltd
Priority to US14/131,912 priority Critical patent/US20140128682A1/en
Priority to EP12751117.8A priority patent/EP2729075A1/fr
Publication of WO2013008176A1 publication Critical patent/WO2013008176A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B17/025—Joint distractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/02—Surgical instruments, devices or methods for holding wounds open, e.g. retractors; Tractors
    • A61B17/025—Joint distractors
    • A61B2017/0256—Joint distractors for the spine
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/041—Controlled or regulated

Definitions

  • the present invention generally relates to apparatus and methods for tissue separation, and more particularly, to apparatus and methods for using an expanding retractor with successively larger dilator elements.
  • a common technique currently employed is passing the tip of a K-wire through tissues to the target location - men passing over the wire a succession of tubes of increasing diameter until reaching the optimal bore size.
  • the drawback of mis procedure is the ever increasing fractional trauma imposed on the tissue being separated.
  • An additional shortcoming of the 'tube' system is that the final cross sectional shape is round.
  • the above technique is not easily applicable as contiguous vital structures like nerves or blood vessels may be damaged in the process.
  • One aspect of the present invention is an apparatus for tissue separation, comprising a hollow retractor expandable in at least one dimension, the retractor having upper and lower guide surface portions for contacting respective upper and lower tissue surfaces; a first dilator having a distal portion configured to fit inside the upper and lower guide surface portions of the retractor so as to expand a distance between the upper and lower guide surface portions of the retractor and thereby separate the upper and lower tissue surfaces by a first distance; and a second dilator having a distal portion configured to fit inside the upper and lower guide surface portions of the retractor so as to expand a distance between the upper and lower guide surface portions of the retractor and thereby render the upper and lower tissue surfaces being separated by a second distance, the second distance greater than the first distance.
  • a nether aspect of the present invention is a method of tissue separation, comprising inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so that a distance between the upper and lower guide surface portions is expandable; inserting a first dilator inside the retractor such mat at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first amount in at least one dimension, the first dilator comprising an elongated body;
  • the retractor in the at least one dimension by successively inserting a second dilator of greater size in the at least one dimension inside the retractor, the inserting performed such mat at least some of a length of the second dilator is placed between the upper and lower guide surface portions so as to further increase the distance between the upper and lower guide surface portions thereby effectuating further separation of the tissue, the second dilator also comprising an elongated body.
  • a still further aspect of the present invention is a method of tissue separation, comprising inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so that a distance between the upper and lower guide surface portions is expandable; inserting a first dilator inside the retractor such that at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first distance, the first dilator comprising an elongated body; expanding the retractor in at least one dimension by inserting a second dilator of greater size in the at least one dimension inside the retractor without removing the first dilator, the inserting performed such that at least some of a length of the second dilator is placed between the upper and lower guide surface portions so as to further increase the distance between the upper and lower guide surface portions thereby effectuating further separation of the
  • a yet still further aspect of the present invention is a method of sizing a limit of tissue separation, comprising (a) assessing a quality of tissue being separated by (i) inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so that a distance between the upper and lower guide surface portions is expandable, and by (ii) inserting a first dilator inside the retractor such that at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first distance; and (b) sizing/assessing a limit to which the tissue is separable by expanding the retractor in at least one dimension by successively inserting a further dilator of successively greater size in the at least one dimension inside the retractor, the inserting performed such that at least some of a length of each of the further dilators is
  • a still further aspect of the present invention is an apparatus for tissue separation, comprising a hollow retractor expandable in at least one dimension, the retractor having upper and lower guide surface portions for contacting respective upper and lower tissue surfaces; a dilator having a distal portion configured to fit inside the upper and lower guide surface portions of the retractor so as to expand a distance between the upper and lower guide surface portions of the retractor and thereby separate the upper and lower tissue surfaces by a first distance.
  • a yet still further aspect of the present invention is a method of using a retractor for an insertion of an element into a human body, comprising inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so that a distance between the upper and lower guide surface portions is expandable; inserting a dilator inside the retractor such that at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first amount in at least one dimension; forming a passageway inside the retractor by removing the dilator, and inserting an implant through the passageway and into the human body.
  • Another aspect of the present invention is a method of using a retractor for an insertion of an element into a human body, comprising inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so that a distance between the upper and lower guide surface portions is expandable; inserting a dilator inside the retractor such that at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first amount in at least one dimension; forming a passageway inside the retractor by removing the dilator, and inserting a surgical tool through the passageway and into the human body.
  • FIG. 1 is an isometric view of a distal portion of retractor, in accordance with one embodiment of the present invention
  • FIG. 2 is an isometric view of a distal portion of tissue separator, in accordance with one embodiment of the present invention.
  • FIG. 3 is an isometric view of a distal portion of a tissue separator of FIG. 2, with the core element of the first dilator removed and the side support element of the first dilator remaining, in accordance with one embodiment of the present invention
  • FIG. 4 is an isometric view of a distal portion of the tissue separator of FIG. 1-3, with a core element of a larger second dilator and the side support element of the first dilator remaining, in accordance with one embodiment of the present invention
  • FIG. 5 is an isometric view of a distal portion of the tissue separator of FIG. 4, with a core element of the larger second dilator remaining and the side support element of the first dilator removed, in accordance with one embodiment of the present invention
  • FIG. 6 is an isometric view of a distal portion of the tissue separator of FIG. 5, with the side support element of the second larger dilator inserted alongside the core element of the second larger dilator, in accordance with one embodiment of the present invention
  • FIG. 6A is an isometric view of a retractor, in accordance with one embodiment of the present invention.
  • FIG. 7 is an isometric view from the side of a retractor with spring arms, in accordance with one embodiment of the present invention
  • FIG. 7A is a schematic view of a retractor with spring arms, in accordance with a different embodiment of the present invention
  • FIG . 8 is an isometric view from the top and side of the retractor with spring arms of FIG. 7, in accordance with one embodiment of the present invention.
  • FIG. 9 is an isometric view from the bottom of the retractor with spring arms of FIG. 7, in accordance with one embodiment of the present invention.
  • FIG. 10A is an isometric view of the retractor of FIG. 7 without a dilator inserted, in accordance with one embodiment of the present invention
  • FIG. 10B is an isometric view of the retractor of FIG. 7 with a dilator inserted, in accordance with one embodiment of the present invention
  • FIG. I0C is an isometric view of the retractor of FIG. 7 with the dilator further inserted, in accordance with one embodiment of the present invention
  • FIG. 10D is an isometric view of the retractor of FIG. 7 with the dilator inserted and causing retraction of the retractor arms, in accordance with one embodiment of the present invention
  • FIG. 1 1 is an isometric view from the side and top of a retractor with hinged arms, in accordance with one embodiment of the present invention
  • FIG. 12 is an isometric view from the side of the retractor with spring arms of FIG. 11, in accordance with one embodiment of the present invention.
  • FIG. 13 is an isometric view from the top of the retractor with spring arms of FIG. 11, in accordance with one embodiment of the present invention.
  • FIG. 14A is an isometric view of the retractor of FIG. 11 without a dilator inserted, in accordance with one embodiment of the present invention
  • FIG. 14B is an isometric view of the retractor of FIG. 11 with a dilator inserted, in accordance with one embodiment of the present invention
  • FIG. 14C is an isometric view of the retractor of FIG. 11 with the dilator further inserted, in accordance with one embodiment of the present invention.
  • FIG. 14D is an isometric view of the retractor of FIG. 11 with the dilator fully inserted, in accordance with one embodiment of the present invention
  • FIG. ISA is an isometric view of a further embodiment of a tissue separator of the present invention including a retractor having flaps, in accordance with one embodiment of the present invention
  • FIG. 1SB is an isometric rear view of the tissue separator of FIG. ISA, in accordance with one embodiment of the present invention
  • FIG. 16A is an isometric view of the tissue separator of FIG. ISA with the dilator forward enough to move the flaps open, in accordance with one embodiment of the present invention
  • FIG. 16B is an isometric rear view of the tissue separator in the position of FIG. 16 A, in accordance with one embodiment of the present invention.
  • FIG. 17A is an isometric view of the tissue separator of FIG. 15A with the dilator further forward, in accordance with one embodiment of the present invention
  • FIG. 17B is an isometric rear view of the tissue separator in the position of FIG. 17 A, in accordance with one embodiment of the present invention.
  • FIG. 18 is an isometric view of a tissue separator inserted between two adjacent vertebrae
  • FIG. 19 is a flow chart of a method, in accordance with one embodiment of the present invention.
  • Fig. 20a is an isometric view of a curved cross-section for upper of lower guide surface portions of a retractor, in accordance with one embodiment of the present invention.
  • Fig. 20b is an isometric view of a flat cross-section for upper of lower guide surface portions of a retractor, in accordance with one embodiment of the present invention.
  • the present invention generally provides a method and apparatus for tissue separation.
  • the tissue separation may be necessary as part of a surgical procedure or operation, for example during a discectomy, for example where it is necessary to increase the gap between two vertebrae.
  • a retractor expandable in at least one dimension, may be inserted into the area of the tissue, for example between discs of a spine.
  • the retractor may have a distal guide surface or surfaces (meaning distal in relation to the surgeon which in this case may mean inside the subject's spine) including upper and lower guide surface portions that may make contact with respective upper and lower tissue surfaces.
  • a first dilator having a distal portion mat can forcibly fit inside the upper and lower guide surface portions of the retractor so as to expand the distance between the upper and lower guide surface portions of the retractor and thereby separate the upper and lower tissue surfaces by a first distance.
  • the first dilator is removed from the retractor and a further dilator that is larger in the dimension mat the tissue dilator is expanded, for example in height, is men inserted into the retractor.
  • the first dilator remains in the retractor while a further second dilator having a larger height in the dimension that the retractor expands in can be inserted forcibly inside the retractor.
  • This may expand the distance between the upper and lower guide surface portions of the retractor and thereby render the upper and lower tissue surfaces being separated by a second distance greater than the first distance.
  • Passage of the dilators may optionally be a tissue sampling procedure as well as a sizing dilation step. Reaching the final dilation may provide information regarding the size of the disc space, consequent preparatory tools (or other tools) as well as the size of the implant that is to be surgically inserted, for example between the vertebrae.
  • the upper and lower guide surface portions of the retractor may, in some preferred embodiments, effectively act like a shoe horn, displacing the adjacent tissue as successive dilators are advanced between the upper and lower guide surface portions while greatly reducing factional trauma to the tissue.
  • the retractor depicted herein may be square in its cross-sectional shape, but it can assume any other shape, regular or irregular, symmetric or asymmetric.
  • the retractor can be used for tissue separation anywhere in the body of humans and non-humans. For the sake of example, the embodiment presented is one of separating tissues on the way to and within the intervertebral disc.
  • a k-wire is inserted within the disc space and its position is verified by a C-arm fluoroscopy.
  • the retractor is passed over the k-wire with the thinner distal end of the retractor penetrating the annulus and its position determined by fluoroscopy.
  • the penetration point through the annulus is at the discretion of the user, all around the annul us, 360 degrees.
  • the retractor may be held secure by a fixator device attached to the operating table - or may be fixed to vertebral screws (or other devices such as spinous process fixation devices) - or may be held manually by the user - or by other means.
  • dilators may be sequentially introduced into it to enlarge at least part of its length the opening and allow passage of instruments, implants and/or materials (such as fusion inducing materials) inwardly and/or passage outwardly (i.e. disc tissue).
  • the proximal portion of the retractor arms typically remains out of the body of the patient/subject and its height may remain constant In the case of disc space procedures, this height typically reaches about 14 mm but may differ according to the specific application of the device.
  • the method and apparatus of the present invention may be used to separate the affected tissue without causing repeated trauma.
  • Successive dilators may be inserted through a hollow retractor expandable in at least one dimension- In this way, only the retractor need contact the tissue. The dilators need not contact the tissue. By inserting successive dilators, the tissue to be separated may be sized without having to successively pass tubes past the tissue.
  • the retractor may have a generally square cross-section.
  • passage of the dilators increasing in size may offer vital information to the user imparted by tactility, i.e.
  • FIG. 1 through FIG. 6 depict successive stages of tissue separation using an apparatus 10 of the present invention, in accordance with a preferred embodiment
  • the more proximal portion of the tissue separator apparatus is not shown.
  • not a l of the length of the retractor is adjustable in the at least one dimension, for example in height Rather, only the distal part of the retractor is adjustable in height
  • the retractor may have a guide portion (also called a guide surface portion) at its distal end 20a, meaning the portion that is configured to contact the tissue.
  • the guide portion of the retractor comprises two guide portions (also called guide surface portions).
  • tissue separator 10 may comprise a hollow retractor 20 expandable in at least one dimension, the retractor having upper and lower guide surface portions for contacting respective upper and lower tissue surfaces.
  • the phrase "upper and lower" guide surface portions or guide surfaces and the individual terms “upper” and “lower” in these phrases should be understood as relative terms in any appropriate dimension, including but not limited to the height dimension. They could, for example, also refer to a width dimension.
  • Tissue separator 10 may also comprise a first dilator 30 having a distal portion configured to fit inside the upper and lower guide surface portions of the retractor so as to expand a distance between the upper and lower guide surface portions of the retractor and thereby separate the upper and lower tissue surfaces by a first distance.
  • the tissue separator 10 may also include a second dilator 40 having a distal portion configured to fit inside the upper and lower guide surface portions of the retractor so as to expand a distance between the upper and lower guide surface portions of the retractor and thereby render the upper and lower tissue surfaces being separated by a second distance, the second distance greater than the first distance.
  • the second dilator may be larger than the first dilator in at least one dimension, for example in the height dimension, which in the context of spinal surgery, can be called the cephalad-caudad dimension.
  • the dilators may be made of any biocompatible material(s), including but not limited to metallic material(s), polymeric material(s) or other or a combination of such materials.
  • the retractor 20 is deformable in at least a distal portion of a length of the retractor 20 to accommodate dilators that are successively larger in at least one dimension.
  • the distal portion may be the last 10%, or in other preferred embodiments, at least 50% of the length of the retractor, or in some preferred embodiments, at least the upper and lower guide surface portions of the retractor.
  • the length of the retractor arm that deforms does not necessarily have to be symmetric to the other retractor arm.
  • one retractor may be fixed and another retractor may be the component that performs all the retraction.
  • one retractor may deform the distal part to a certain amount while the other retractor deforms to a different amount (either more or less man the first retractor.
  • the retractor 20, or at least the upper and lower guide surface portions may be deformable as a result of being made from plastic and/or superelastic material.
  • the upper and lower guide surface portions may be formed from Nitinol superelastic materials, allowing them to smoothly deform to accommodate successively wider dilators advancing between the upper and lower guide surface elements, and then return to their original form.
  • the guide surface portions may be plastically deformed during insertion of the dilators.
  • the retractor 20 comprises retractor arms 22a, 24a defined by upper and lower U-shaped walls 22, 24, as shown in FIG. 1.
  • the retractors arms 22a, 24a may contact one another, i.e. the legs 28, 25 of the U-shaped walls 22, 24 may contact one another.
  • the cross-sectional shape of retractor 20 (and of tissue separator 10 as a whole including dilator 30) may be generally rectangular, and in some cases square or generally square, to facilitate correct orientation.
  • the cross-sectional shape may be generally rectangular at a distal end 20a (as measured relative to the user not the patient) of the retractor 20.
  • the cross- sectional shape of the upper and lower guide surface portions may extend across a majority of a length or in other preferred embodiments a full length of the retractor.
  • the height as measured between the upper and lower guide surface portions 21, 23 of retractor arms 22a, 24a may generally be the same as the height of more proximal portions of retractor arms.
  • the retractor 20 may have a fixed distance between upper and lower walls and the upper and lower guide surface portions 21, 23 may be expandable from one or more positions narrower than the fixed distance.
  • each of the first and second dilators may comprise a core element and a support element, the support element located on a side of the core element
  • first dilator 30 may include core element 32 and support element 36 while second dilator 40 may include core element 42 and support element 46.
  • First dilator 30 may comprise a core element 32 (sometimes called a first core element since it is the core element of the first dilator 30) that has at least a top surface 34 and a bottom surface 35, and may comprise a support element 36 (also sometimes referred to as a first support element 46 since it is the support element for the first dilator 30) that may have at least one side wall 36a, and in a preferred embodiment two (left and right) side walls 36a, 36b.
  • a core element 32 sometimes called a first core element since it is the core element of the first dilator 30
  • a support element 36 also sometimes referred to as a first support element 46 since it is the support element for the first dilator 30
  • second dilator 40 may comprise a core element 42 (sometimes called a second core element since it is the core element of the second dilator 40) mat has at least a top surface 44 and a bottom surface 45, and may comprise a support element 46 (also sometimes referred to as a second support element 46 since it is the support element for the second dilator 40) that may have at least one side wall 46a, and in a preferred embodiment two (left and right) side walls 46a, 46b.
  • a core element 42 sometimes called a second core element since it is the core element of the second dilator 40
  • a support element 46 also sometimes referred to as a second support element 46 since it is the support element for the second dilator 40
  • FIG. 3 depicts a stage in which core element 32 of first dilator 30 has been pulled out and the side support elements 36a, 36b remains in order to support the structure of retractor 20, i.e. so that retractor arms 22a, 24a do not collapse to contact one another as in FIG. 1.
  • a working tunnel has been created for surgical (or other) use.
  • dilator core element 32, 42 is hollow and the working tunnel is available anyway.
  • FIG. 4 depicts the stage after a core element 42 of a larger size dilator, i.e. second dilator 40 has been inserted through retractor arms 22a, 24a. Accordingly, it depicts a stage where inside the retractor 20 there is a core element 42 of second dilator 40 that is together in the retractor with a support element 36 of a different dilator (first dilator 30), the different dilator being smaller in size than the second dilator 40.
  • the core element 42 has a top and bottom surface.
  • the support element 36 has at least one side wall.
  • the support element may be removable from the retractor without the core element having to be removed.
  • First dilator 30 may have a first core element and a first support element of a first size and second dilator 40 may have a second core element and a second support element of a second size.
  • first core element 32 and first support element 36 may both be 7 mm in height (as measured by the distance between retractor arms 22a, 24a) whereas second core element 42 and second support element 46 may be 9 mm in height (as measured by the distance between retractor arms 22a, 24a).
  • the core element of a dilator is slightly larger or slightly smaller (for example plus or minus 1% or 2% or 4% or 5% or 7% or 10% or 15% or more) than the support element (i.e. side walls) of that dilator.
  • FIG. 5 depicts a stage in which the support element 36, i.e. the side support walls 36a, 36b of the first dilator 30 have been pulled out of retractor 10. Accordingly, the core element 42 of second dilator 40 is supporting the upper U-shaped walls 22 of retractor arm 22a and preventing it from contacting lower U-shaped walls 24.
  • FIG. 6 depicts the stage in which the second support element 46, i.e. the side support walls 46a, 46b, of second dilator 40, has been inserted. This completes the cycle of expanding the tissue separator 10.
  • tissue separator 10 may be further expanded in at least one dimension, i.e. height, from 9 mm to 11 mm.
  • a still further expansion may be done with a fourth dilator (not shown) whose core element and support element are of a fourth size to further expand the tissue separator 10 from the at least one dimension, i.e. height from 11 mm to 13 mm.
  • any of the dilators in the method and apparatus of the present invention may be greater than, equal to, or less than the length of the retractor 20.
  • any of the dilators may be positioned relative to the retractor so that the dilator extends distally beyond the retractor.
  • the purpose of having a dilator extend beyond the retractor may be so mat (a) the dilator may reach extend beyond the retractor tips and pierce/dilate/expand/manipulate tissue that is exterior to the retractor tips, and/or (b) the dilation may be very gradual (i.e. dilator tip may have a small angle).
  • Tissue separator 10 may thereby comprise a hollow retractor 20 expandable in at least one dimension, the retractor having upper and lower guide surface portions 21, 23 for contacting respective upper and lower tissue surfaces.
  • the apparatus may also include a dilator 30 having a distal portion configured to fit inside the upper and lower guide surface portions of the retractor so as to expand a distance between the upper and lower guide surface portions of the retractor and thereby separate the upper and lower tissue surfaces by a first distance.
  • the apparatus may include a mechanism for maintaining the hollow retractor in a retracted position with a set distance between the upper and lower guide surface portions when the dilator is removed before being replaced with a dilator of a different size.
  • this mechanism for maintaining the retractor is comprised of the retractor, for example the retractor arms, having upper and lower U-shaped walls and may be further comprised of the dilator having a core element 32 and a support element 36 that may have at least one side wall, wherein the support element 36 may be located on a side of the core element 32.
  • the core element 32 may have a top and bottom surface.
  • the core element 32 may be removable from the retractor without the support element having to be removed from the retractor.
  • the mechanism for maintaining the retractor in a retracted position may be a hinge mechanism (for example hinge mechanism 250 as seen in FIG. 12) at a proximal end of the retractor for fixing a position of one or more retractor arms. This is described in FIGS. 7-14D.
  • the mechanism for maintaining the retractor is a retracted position may be a ratchet mechanism (not shown).
  • the retractor of the present invention (20, 120, 220, 320) is expandable in a height dimension.
  • the retractor is expandable in a height dimension and in a width dimension. This is necessary in certain surgical environments. Enlargement of the opening may vary taking into consideration the point of penetration: in the case of PLIF or TLIF procedures, the opening preferably gains only in height (in the sagittal plane, (i.e., the cephalad-caudad dimension)) as sideways/lateral widening of the entrance may compromise the adjacent nerve root and/or dura.
  • the width of the retractor may be fixed and may not change all along the instrument If the penetration is through the anterior annulus as in ALIF (or through soft tissue), widening may be concomitantly done sideways as well. If the widening is in more than one direction, the widening may be simultaneous in the plurality of directions or each direction widened in sequence.
  • the guide surface portions of retractor arms 22a, 24a may be comprised of opposing guide surfaces.
  • the guide surface portions in any preferred embodiment of the present invention may be flat (see, e.g. FIG. 20B), may be rounded (see, e.g. FIG. 20A) or may be a combination of the two or other possibilities (i.e. chamfered for example).
  • FIGS. 20a, 20b relate to guide surface portions 21 , 23 of retractor 20, the range of shapes applies to all preferred embodiments.
  • the guide surface portions may also be parallel to one another, although this is not required in all cases.
  • the guide surface may be a single continuous surface, for example conical, and the upper and lower guide surface portions may be selected segments or portions of this single continuous surface.
  • the upper and lower surface guide portions in expanding the distance between the upper and lower surface guide portions, may be moved symmetrically or asymmetrically and may or may not have an equal share in performing the retraction.
  • the length of one retractor arm that deforms or moves against the tissue may differ from the length of the other retractor arm mat deforms or moves against the tissue.
  • the upper retractor arm's upper surface guide portion may have more of its length deform or move than the lower retractor arm's lower surface guide portion.
  • the quantity of the retraction movement may be more or less for one retractor arm's surface guide portion man for another.
  • This which may appear in certain preferred embodiments, is, as shown in FIG.
  • one retractor arm here, the lower retractor arm
  • the other retractor arm converges down to the distal tip of the first retractor arm prior to retraction.
  • all of the tissue separation will be performed by retraction of the upper surface guide portion forming part of the upper retractor arm, with the other arm retractor arm remaining fixed.
  • one retractor arm's surface guide portion may retract or deform to a certain amount while the other retractor deforms to a different amount (either more or less than the first retractor arm's surface guide portion.
  • the tissue separator 100 includes a retractor 120 and a dilator of a first size.
  • Retractor 120 has upper and lower spring arms 122a, 124a including upper and lower guide surface portions 122, 124 thereof.
  • the spring arms 122a, 124a may be rigidly connected to the base 99, or connected by a moveable axis, or similar means.
  • Each spring arm 122a, 124a may be connected to the base 99 by the same or different mechanism.
  • one arm may be rigid (without elastic/spring features) while the other arm bends and or moves/rotates. As shown in FIG. 7 and FIG.
  • the tips 127, 129 of the upper and lower guide surface portions 122, 124 of retractor 120 may be urged to contact one another before insertion of the first dilator 130 or the second dilator 140 inside retractor 20.
  • upper and lower spring arms 122a, 124a converge at a tip 127, 129, the tip comprising part of the upper and lower guide surface portions 122, 124.
  • FIGS. 10A through 10D shown various stages of insertion of a dilator into the retractor 120 of tissue separator 100.
  • the retractor 120 has been inserted into the tissue of the subject but no dilator has been inserted.
  • first dilator 130 has been partially inserted but not to the point where the upper and lower guide surface portions of retractor 120 have been retracted.
  • FIG. I0C the first dilator 130 is about to reach the upper and power guide surface portions.
  • FIG. 10D shows the stage where first dilator 130 has expanded the distance between the upper and lower guide surface portions.
  • the dilators may or may not be hollow.
  • the first dilator is removed and a larger second dilator 140 is inserted. In the converse situation, a larger dilator is removed and a smaller dilator is inserted.
  • the tissue separator 200 includes a retractor 220 and a first dilator 230.
  • a hinge mechanism 250 at a proximal end of the retractor 220 may be used for initial retraction of the upper and lower guide surface portions 222, 224 to a distance mat may allow upper and lower guide surface portions 222, 224 to abut the respective upper and lower tissue surfaces 11, 12 without actually retracting the tissue surfaces.
  • the hinge mechanism 2S0 may be controlled by a screw mechanism 260 that controls how far apart the upper and lower guide surface portions of the retractor arms are.
  • the screw mechanism 260 may also set a maximum retraction of the upper and lower guide surface portions 222, 224, i.e. the maximum retraction distance of the upper and lower guide surface portions 222, 224 achievable with a particular first dilator or a particular second or further dilator.
  • the screw mechanism 260 may be used to retract the retractor arms to a distance of 4 mm so that the upper and lower guide surface portions abut the upper and lower tissue surfaces.
  • the screw mechanism may also be set to a maximum distance of 7 mm to accommodate first dilator 230.
  • FIGS. 14A through 14D shown various stages of insertion of a dilator into the retractor 220.
  • the retractor 220 has been inserted into the tissue of the subject in its closed position with the tips touching (and no dilator has been inserted).
  • the retractor arms are opened with the screw mechanism by turning the knob to reach an initial retraction position seen in FIG. 14 A.
  • first dilator 230 has been partially inserted but not to the point where tile upper and lower guide surface portions 222, 224 of retractor 220 have been further retracted (fix this figure the tips should be open like in 14A).
  • FIG. 14 A the retractor 220 has been inserted into the tissue of the subject in its closed position with the tips touching (and no dilator has been inserted).
  • the retractor arms are opened with the screw mechanism by turning the knob to reach an initial retraction position seen in FIG. 14 A.
  • first dilator 230 has been partially inserted but not to the point where tile upper and lower guide surface portions 222
  • FIG. 14C shows the first dilator 230 is about to reach the upper and power guide surface portions 222, 224.
  • FIG. 14D shows the stage where first dilator 230 has expanded the distance between the upper and lower guide surface portions 222, 224 to its maximum dilation position previously set by the screw mechanism.
  • tile first dilator is removed and a larger second dilator 240 is inserted.
  • a larger dilator is removed and a smaller dilator is inserted.
  • FIGS. 15A-B shows a tissue separator 300 comprising a retractor 320 and a dilator 330.
  • the upper and lower guide surface portions 322, 324 of the retractor 320 may comprise flaps 327 that may be situated distal to a binge 328 of the retractor 320.
  • Hinge 328 may be integrally joined to the retractor arms 322a, 322b and may extend from an integral joint 329a on the retractor arms to a further joint 329b adjacent a base 327b (FIG. 17B) of flaps 327.
  • flaps 327 may extend directly from integral joint 329a. As shown in FIGS.
  • flaps 327 are in a constricted position.
  • FIG. 16A-B when dilator 330 is inserted and in a partially forward position, dilator 330 bumps into hinge 328 which moves flaps 327 outward.
  • FIGS. 17A-B depicts the position where the dilator 330 has been moved even further forward. In this case flaps 327 have reverted to an almost constricted position due to pressure from the tissue. .
  • hinge 328 on the surface of the retractor may be a double hinge comprising two or more joints (integral joints 329a, 329b) and the area between them.
  • the medial wall 325 of the retractor 320 which is the rear wall of the tissue separator 300 spanning the top and bottom surfaces of the retractor 320, may preferably be reinforced all along its length.
  • the flaps 327 may be made of any suitable material including, but not limited to, metal or metal alloys (collectively metallic material) and biocompatible plastics or other polymers.
  • Method 400 may comprise a step 410 of inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so that a distance between the upper and lower guide surface portions is expandable.
  • Method 400 may also include a step 420 of inserting a first dilator inside the retractor such that at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first amount in at least one dimension.
  • the first dilator may utilize any of the embodiments described for the apparatus of the present invention and may comprise an elongated body.
  • a further step 430 of method 400 may be expanding the retractor in the at least one dimension by inserting a second dilator of greater size in the at least one dimension inside the retractor, the inserting performed such that at least some of a length of the second dilator is placed between the upper and lower guide surface portions so as to further increase the distance between the upper and lower guide surface portions thereby effectuating further separation of the tissue by a greater distance.
  • the second dilator may utilize any of the embodiments described for the apparatus of the present invention and may comprise an elongated body.
  • the first and further dilators may be inserted into the retractor without the first and further dilators contacting the upper and lower tissue surfaces.
  • the method 400 also may involve effectuating still further dilation by successively inserting one or more further dilators (beyond the second dilator) between the upper and lower guide surface portions so as to further increase the distance between the upper and lower guide surface portions by successively greater amounts.
  • the number of such further dilators may be one, at least one, two, at least two, three, at least three, four, at least four, five, at least five, or a higher number, as needed.
  • the expanding the retractor further includes successively removing a dilator before successively inserting the second dilator (or the further dilator).
  • Method 400 may utilize any of the embodiments of tissue separator 10, 100, 200, 300.
  • inserting the retractor into a tissue involves inserting opposing upper and lower U-shaped walls into the tissue.
  • the second dilator (and any further dilator) may comprise a core element and a support element, and the expanding the retractor may comprise first replacing the core element of a first size of the first dilator with a core element of a second size of the second dilator, the second size core element larger than the first size core element, and then afterwards replacing the support element of a first size of the first dilator with a support element of a second size of the second dilator, the second size support element larger than the first size support element
  • each dilator (and any further dilator) may comprise a core element and a support element, and wherein the expanding the retractor comprises removing the core element of a particular dilator (for example the first dilator) before
  • inserting the core element of the second dilator may be preceded by removing the core element of the first dilator.
  • each of the first dilator and second dilator may comprise a core element and a support element
  • a multiple expansion of the retractor may comprise first expanding the retractor by removing the core element of the first dilator, inserting the core element of the second dilator of a second size before removing the support element of the first dilator, removing the support element of the first dilator, inserting the support element of the second dilator, and then further expanding the retractor including by removing the core element of the second dilator and inserting a core element of a third dilator before removing the support element of the second dilator.
  • the process between the second and third dilators may be continued similar to the process between the first and second dilators.
  • the core element is replaced before the support element is replaced.
  • the method 400 may involve using a hinge to move the upper and lower guide surface portions to an initial distance prior to inserting the first dilator, the hinge also setting a maximum retraction of the upper and lower guide surface portions for the first dilator.
  • the method 400 may also involve using the hinge to move the upper and lower guide surface portions to an initial distance prior to inserting the second dilator, the hinge also setting a maximum retraction of the upper and lower guide surface portions for the second dilator.
  • method 400 may have a further step of configuring the upper and lower guide surface portions to converge at distal tips at an initial position and to be expanded by insertion of the first and second dilators.
  • method 400 may also comprise a step wherein the first and second dilators each move flaps at the upper and lower guide surface portions of the retractor.
  • a first step may involve inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so mat a distance between the upper and lower guide surface portions is expandable.
  • a second step may involve inserting a first dilator inside the retractor such that at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first distance.
  • the first dilator may comprise an elongated body.
  • a third step may be expanding the retractor in at least one dimension by insetting a second dilator of greater size in the at least one dimension inside the retractor without removing previously inserted first dilator. This may be accomplished in a variety of ways, for example by using dilators whose outer walls are flexible and hollow.
  • the inserting may be performed such mat at least some of a length of the second dilator is placed between the upper and lower guide surface portions so as to further increase the distance between the upper and lower guide surface portions thereby eSectuating further separation of the tissue by a greater distance.
  • the second dilator may also comprise an elongated body.
  • the method of sizing a limit of tissue separation may comprise a first step of (a) assessing a quality of tissue being separated by
  • a second step may involve (b) sizing/assessing a limit to which tile tissue is separable by expanding the retractor in at least one dimension by successively inserting a further dilator of successively greater size in the at least one dimension inside the retractor, the inserting performed such that at least some of a length of each of the further dilators is placed between the upper and lower guide surface portions so as to further increase the distance between the upper and lower guide surface portions thereby effectuating further separation of the tissue by successively greater distances.
  • the second step includes removing a dilator before a further dilator is inserted.
  • the present invention may also be characterized as a method of using a retractor for an insertion of an element into a human body.
  • This method may comprise a step of inserting a retractor into a tissue, the retractor having upper and lower guide surface portions that contact respective upper and lower tissue surfaces, the retractor expandable in at least one dimension so that a distance between the upper and lower guide surface portions is expandable.
  • Thi method may also include a further step of inserting a dilator inside the retractor such that at least some of a length of the first dilator is placed between the upper and lower guide surface portions so as to increase a distance between the upper and lower guide surface portions and effectuate separation of the tissue by a first amount in at least one dimension.
  • a further step of the method may be forming a passageway inside the retractor by removing the dilator.
  • the method may also involve a step of inserting (i) an implant, (ii) a surgical tool or (iii) an implant and a surgical tool, through the passageway and into the human body.
  • the surface guide portions may have teeth ri dges protrusions externally on the ends that may be embedded into the tissue (endplate or other) to provide at least some fixation of the retractor to the tissue.
  • the upper and lower surface guide portions may have internally facing protrusions (stoppers) to prevent dilators or other instruments from advancing beyond the tip of the retractor.
  • the upper and lower guide surface portions typically conform to the surface of the tissue against which they are pressed as the dilator advances, remaining substantially parallel to each other.
  • the thickness of the guide portions may be variable so as to define a single or more preferably double hinge arrangement, with the distal part of the guide portion being relatively more rigid, and being forced outwards as a unit, thereby spreading the applied pressure more evenly across a relatively large area of tissue.
  • two pairs of guide surface portions may be used, and successive dilators may increase, either simultaneously or intermittently, in both dimensions.
  • a single sequence of dilators may be used with each being inserted in two orientations to separately increase both height and width dimensions.
  • the apparatus of the present invention can be a universal tool that incorporates other inventive concepts.
  • the apparatus is used according to the "Nonlinear" concept (i.e., as a part of a system and method as described in various prior co-assigned patent applications) in which the tools and implants are deflected into circuitous trajectories, the medial wall of the retractor may be reinforced to enable curling of the multi-link structures around the distal end of the wall.

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Abstract

La présente invention concerne un appareil destiné à séparer les tissus qui comprend un rétracteur creux pouvant s'étendre dans au moins une dimension, le rétracteur ayant des parties surface de guidage supérieure et inférieure destinées à être en contact avec les surfaces tissulaires supérieure et inférieure respectives ; un premier dilatateur ayant une partie distale configurée pour s'adapter à l'intérieur des parties surface de guidage supérieure et inférieure du rétracteur de manière à mettre une distance entre les parties surface de guidage supérieure et inférieure du rétracteur et à ainsi séparer les surfaces tissulaires supérieure et inférieure d'une première distance ; et un second dilatateur ayant une partie distale configurée pour s'adapter à l'intérieur des parties surface de guidage supérieure et inférieure du rétracteur de manière à mettre une distance entre les parties surface de guidage supérieure et inférieure du rétracteur et à ainsi séparer les surfaces tissulaires supérieure et inférieure d'une seconde distance ; la seconde distance étant supérieure à la première distance.
PCT/IB2012/053516 2011-07-10 2012-07-10 Rétracteur Ceased WO2013008176A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
US14/131,912 US20140128682A1 (en) 2011-07-10 2012-07-10 Retractor tool
EP12751117.8A EP2729075A1 (fr) 2011-07-10 2012-07-10 Rétracteur

Applications Claiming Priority (2)

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US201161506102P 2011-07-10 2011-07-10
US61/506,102 2011-07-10

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WO2013008176A1 true WO2013008176A1 (fr) 2013-01-17

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US9808232B2 (en) * 2011-11-01 2017-11-07 DePuy Synthes Products, Inc. Dilation system
WO2015138317A1 (fr) 2014-03-10 2015-09-17 Stryker Corporation Système de positionnement de membre
US9795370B2 (en) 2014-08-13 2017-10-24 Nuvasive, Inc. Minimally disruptive retractor and associated methods for spinal surgery
US9951904B2 (en) 2015-03-24 2018-04-24 Stryker Corporation Rotatable seat clamps for rail clamp
US10905566B2 (en) * 2018-02-05 2021-02-02 Spineology Inc. Percutaneous posterior implant slide
US10363023B1 (en) * 2019-02-12 2019-07-30 Edward Rustamzadeh Lateral retractor system for minimizing muscle damage in spinal surgery
US10925593B2 (en) 2019-02-12 2021-02-23 Edward Rustamzadeh Lateral retractor system for minimizing muscle damage in spinal surgery
US12016543B2 (en) 2019-02-12 2024-06-25 Edward Rustamzadeh Lateral retractor system for minimizing muscle damage in spinal surgery
US11246582B2 (en) 2019-02-12 2022-02-15 Edward Rustamzadeh Dual-motion rotation and retraction system for minimizing muscle damage in spinal surgery
USD1002842S1 (en) 2021-06-29 2023-10-24 Edward Rustamzadeh Combination surgical spinal dilator and retractor system

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US20140128682A1 (en) 2014-05-08

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